Results from several genome-wide association (GWA) studies have recently emerged showcasing the discovery of specific genetic variations found to be associated with several common, complex diseases. Leveraging these findings and fueled by the rapidly decreasing costs of performing genome-wide single nucleotide polymorphism (SNP) scans, a small number of companies have begun offering tests that aim to calculate an individual's risk for these common diseases using this genome-wide technology, direct-to-consumer (DTC) over the internet. While the offering of these tests - both at this stage of scientific discovery and directly to the consumer - has been the subject of much intense controversy, it is nevertheless the case that many individual consumers are purchasing these products. Despite this, however, relatively little is known about the characteristics of consumers of DTC personal genomics services, including why they chose to pursue this type of testing, and perhaps most critically, how they are responding to their results. The Scripps Genomic Health Initiative (SGHI) represents an opportunity to begin to address these questions. The SGHI is a large longitudinal cohort study in which participants purchase the Navigenics Health Compass DTC genomic risk assessment product at a discounted rate and are administered baseline (i.e., pre-risk disclosure), as well as 3- and 12-month follow-up (i.e., post-risk disclosure) web-based demographic, family medical history, and behavioral health assessments. In addition, items pertaining to attitudes about genetic testing and the perceived impact of the results, including distress related to receiving information pertaining to one's genomic risk profile, are administered. The SGHI is, to a large degree, exploratory in that it is one of the first studies to evaluate response to testing among individual consumers of DTC personal genomics services. To date, over 4,000 individuals have enrolled in the SGHI, and although the ongoing recruitment of individuals into the study is currently funded, analysis of the assessment data that is being collected is unfunded. Therefore, we are requesting two years of funding via the NIH Exploratory/Developmental Research Grant Program (R21) for analysis of these data. Our specific aims are as follows: First we will characterize consumers of DTC personal genomics services in terms of their demographics, baseline level of genetic risk for disease, behavioral health characteristics, and attitudes regarding genetic testing. Second, we will assess response to testing among consumers with respect to general anxiety and distress related to testing, perception of new disease risk, changes in health behaviors, and attitudes regarding the impact of results. Third, we will evaluate potential moderators of response to testing, including demographic characteristics, perception of risk, risk estimates reported in the Health Compass, and utilization of genetic counseling services. PUBLIC HEALTH RELEVANCE: The proposed project would leverage data from the Scripps Genomic Health Initiative (SGHI), a large longitudinal cohort study of over 4,000 consumers of GWAS-based DTC personal genomics services (i.e., specifically the Navigenics Health Compass product). We aim to characterize consumers of DTC personal genomics services, as well as assess behavioral and psychological response to DTC genetic testing, including potential moderators of response such as level of genetic risk and utilization of genetic counseling services. At this time there is essentially nothing known about the impact of this technology on consumers despite its relatively wide availability and the fact that many individual consumers have already purchased these products. Thus, the proposed work will provide an initial examination of these important questions to which timely answers are critical given efforts currently underway to determine how best to regulate the sale and use of these tests.